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This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (RT) | Other | [Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: • Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal. |
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| Sequence B (TR) | Other | [Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: • Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide SR 150mg after high-fat meal | Drug | Test Drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak Plasma Concentration of Rebamipide | From Period1/ Day1 to Period2/Day9 |
| AUClast of Rebamipide | Area Under the plasma concentration versus time curve last of Rebamipide | From Period1/ Day1 to Period2/Day9 |
| Measure | Description | Time Frame |
|---|---|---|
| t1/2 β of Rebamipide | Time taken for half the initial dose of Rebamipide administered to be eliminated from the body | From Period1/ Day1 to Period2/Day9 |
| Tmax of Rebamipide | Time at which the Cmax of Rebamipide is observed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Bundang | Gyeonggi-do | 13496 | South Korea |
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| Rebamipide SR 150mg under fasting condition |
| Drug |
Reference Drug |
|
| From Period1/ Day1 to Period2/Day9 |
| AUCinf of Rebamipide | Area Under the plasma concentration versus time curve inifinite of Rebamipide | From Period1/ Day1 to Period2/Day9 |